Principle Process Engineer

Blackfield Associates are currently partnered with a global pharmaceutical manufacturer to support their search for a Principle Process Engineer to join their project based in North Carolina on a fulltime permanent basis. Key Responsibilities Provide technical leadership for the design, implementation, commissioning, qualification, and start-up of aseptic drug product manufacturing systems, including compounding, equipment preparation, and aseptic filling operations. Lead the development of engineering deliverables, including user requirements specifications, process flow diagrams, P&IDs, equipment data sheets, and technical specifications. Oversee the design and integration of aseptic drug product systems, including filling lines, isolators, compounding equipment, single-use technologies, autoclaves, parts washers, filter integrity testing systems, and cleaning and sterilization equipment. Evaluate and manage equipment vendors, engineering partners, and contractors throughout design, procurement, installation, and start-up activities. Lead FAT, SAT, commissioning, qualification, and operational readiness activities to ensure systems are delivered safely, compliantly, and fit for purpose. Drive technical troubleshooting and resolution of complex equipment, process, and regulatory challenges during project execution and start-up. Coordinate activities across Manufacturing, MSAT, Quality, Facilities, Procurement, Engineering, Construction, and EHS teams to ensure alignment and project success. Ensure compliance with cGMP requirements, FDA regulations, EU Annex 1 guidance, contamination control strategies, and company quality standards. Support project controls, scheduling, procurement, and construction activities to maintain progress against project milestones. Drive continuous improvement and innovation by applying industry best practices, emerging technologies, and benchmarking insights to process and equipment design. Experience Required Bachelor’s degree in Engineering, preferably Mechanical or Chemical Engineering. Advanced degree preferred. Sufficient experience in process engineering and capital project delivery within aseptic biopharmaceutical or drug product manufacturing environments. Proven experience leading the design, installation, commissioning, qualification, and start-up of aseptic drug product manufacturing systems. Strong expertise in aseptic filling operations, aseptic compounding processes, equipment preparation systems, and contamination control strategies. Hands-on experience with filling lines, isolators, single-use technologies, compounding systems, autoclaves, parts washers, COP/SOP systems, and filter integrity testing equipment. Deep understanding of FDA cGMP regulations, EU Annex 1 requirements, commissioning and qualification methodologies, and aseptic manufacturing principles. Experience managing equipment vendors, engineering firms, construction contractors, and multidisciplinary project teams on large capital projects. Strong knowledge of pharmaceutical facility design, project controls, procurement processes, construction execution, and operational readiness planning. Proven ability to solve complex technical challenges, lead cross-functional teams, and drive projects through all phases of execution. Experience supporting greenfield or brownfield biopharmaceutical facility projects is highly desirable. Previous experience delivering large-scale aseptic manufacturing capital projects and transitioning systems from design through commercial operation is preferred. #J-18808-Ljbffr Blackfield Associates